Clinical trial · Interventional
A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly Patients After Urological Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex).Observation contents: Whether there is postoperative delirium and its severity: 3D - CAM assessment scale, DMAS assessment scale; awakening time, extubation time, PACU stay time, hospital stay time; 1 - 7 days after surgery or before discharge, POD assessment and pain - sleep assessment, the first time getting out of bed; postoperative complications; adverse reactions; adverse events, and so on.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Tumor | Kidney Neoplasm | ALIAS | 0.90 |
| Postoperative Delirium (POD) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcranial Magnetic Stimulation Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perform transcranial magnetic stimulation on elderly patients undergoing urological surgery
- description
- Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex)
- interventionNames
- Device: Transcranial Magnetic Stimulation Device
Primary outcomes (1)
- measure
- Incidence of postoperative delirium within 7 days after surgery.
- timeFrame
- From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon
- description
- In the anesthesia recovery room, the CAM-ICU(The Confusion Assessment method for the ICU ) scale was performed 30 min after extubation. Postoperative delirium was measured by the 3D-CAM (The 3-Minute Diagnostic Confusion Assessment Method)scale from postoperative day 1 until postoperative day 7 or before discharge from the hospital. The CAM scale includes four major features: 1. Acute onset or fluctuating changes in condition 2. Inattention 3. Confusion 4. Changes in level of consciousness. Delirium is diagnosed when features 1 and 2 are positive at the same time, and/or features 3 and 4 are positive.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria:(1) Age ≥ 60 years old; (2) Patients scheduled for elective urological surgery under general anesthesia with tracheal intubation; (3) ASA classification I - III; (4) Estimated operation duration ≥ 2 hours; (5) Informed consent from the patient or their guardian; (6) Proficient in communicating in Chinese. - Exclusion Criteria:(1) Patients with permanent lack of autonomy (2) Not applicable for delirium assessment: including language disorders, deafness, blindness or aphasia, coma (3) With treatment abandonment or brain death (4) Known pregnancy or lactation (5) Unable to obtain consent according to national regulations (6) Patients forcibly hospitalized by regulatory authorities (compulsory measures) (7) With cardiac pacemaker or stent implantation (8) Patients with delirium (9) Patients with known brain lesions (10) Patients with known epilepsy history, having taken drugs that can cause epileptic seizures, having metal implants in the neck or brain, or having cerebral hemorrhage ，Acute phase, acute infectious diseases (11) Habitual treatment with antipsychotic drugs (12) Received antipsychotic drug treatment in the ICU before enrollment (13) Patients with severe liver dysfunction (Child-Pugh C grade) (14) Patients with severe kidney dysfunction (requiring dialysis before surgery) (15) Severe heart failure (METS \< 4) (16) Preoperative cognitive impairment as determined by a MoCA evaluation prior to surgery; \-
References
Publications (0)
Data not yet available